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January 2017 Blog Posts (22)

Water System Validation in Pharmaceuticals Industry 2017

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of…

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Added by John Robinson on January 31, 2017 at 5:09am — No Comments

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn't this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant,…

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Added by John Robinson on January 25, 2017 at 4:58am — No Comments

Recommended Practices for Anti-Retaliation Programs

WASHINGTON - The Occupational Safety and Health Administration today issued Recommended Practices for Anti-Retaliation Programs to help employers create workplaces in which workers feel comfortable voicing their concerns without fear of retaliation. The recommendations are intended to apply to all…

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Added by Henry Wilter on January 24, 2017 at 6:34pm — No Comments

Management for Medical Device Industry

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.

While many global…

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Added by John Robinson on January 23, 2017 at 7:46am — No Comments

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is prescriptive and hierarchical,…

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Added by John Robinson on January 20, 2017 at 5:50am — No Comments

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects for a number of valid reasons. One of the main reasons is that medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug “active pharmaceutical ingredients” to achieve the clinical therapeutic effect.…

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Added by Adam Fleming on January 20, 2017 at 5:19am — No Comments

Sweating Slab Syndrome Safety Hazards

Sweating Slab Syndrome presents many dangers in industrial facilities and other buildings that have concrete floors. 

Sweating Slab Syndrome is characterized by the regular formation of condensation on a concrete floor. Not only can this lead to slips and falls, but can also lead to mold growth and many other dangers.

Go Fan Yourself has created an infographic that highlights the dangers of Sweating Slab Syndrome and provides some tips for alleviating Sweating Slab…

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Added by Nikki Heinkel on January 19, 2017 at 12:18pm — No Comments

Working at height is one of the UK's leading causes of workplace fatalities & injuries. These pointers will reduce risks & make working at height safer.

Working at height is the leading cause of workplace fatalities & injuries in the UK. In 2013/14, the Health and Safety Executive published statistics which showed that working at height was responsible for more workplace fatalities than any other professional activity. It also revealed that working at height was the…

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Added by Alex on January 19, 2017 at 12:04pm — No Comments

Alternatives to AQL sampling plans do exist

Alternatives to AQL sampling plans do exist, but companies need to be aware of them and explore them. Acceptance Quality Limit, or AQL, is applied as a benchmark in most manufacturing organizations to inspect the quality of products they purchase. It is only when the product meets AQL that the receipt is acknowledged and the payment made.

So, what is AQL?

What is AQL? In simple terms, AQL, which expands to Acceptance Quality Limit, is what…

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Added by Adam Fleming on January 19, 2017 at 5:06am — No Comments

FDA Regulation of Combination Products is important to understand

FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does…

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Added by Adam Fleming on January 18, 2017 at 5:02am — No Comments

Post market surveillance needs to be robust to avoid penal regulatory action

Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.

Post market surveillance is, in simple terms, the monitoring of the performance and…

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Added by Adam Fleming on January 17, 2017 at 6:56am — No Comments

Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring the…

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Added by John Robinson on January 16, 2017 at 5:46am — No Comments

How to implement 21 CFR Part 11, which is about Compliance for Electronic Records and Signatures?

How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes…

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Added by John Robinson on January 13, 2017 at 5:17am — No Comments

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines…

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Added by John Robinson on January 13, 2017 at 4:30am — No Comments

Regulatory Filing Requirements for medical devices in Japan

Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…

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Added by John Robinson on January 12, 2017 at 4:51am — No Comments

Work tools: key stats and areas of concern

Although we all know intuitively that power tools can be exceptionally dangerous if used without due care and attention, it remains far too easy to fall into the trap of thinking that the ones we’re most accustomed to are somehow made safer by dint of our familiarity with them.

 

However, numerous eye-opening statistics have been gathered in recent years to…

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Added by Alex on January 11, 2017 at 11:04am — No Comments

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of…

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Added by John Robinson on January 11, 2017 at 5:01am — No Comments

HIPAA Security Rule

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself…

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Added by John Robinson on January 10, 2017 at 4:41am — No Comments

Emerging Issues in Food Safety-Globally

The Global Food Safety Initiative is a private enterprise by those in the food industry aimed at offering guidance to the food industry for making food chain safer. This industry-driven initiative seeks to provide thought leadership on the various aspects of food and guides the food industry on implementing safety standards along all the points in the food…

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Added by John Robinson on January 9, 2017 at 6:42am — No Comments

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.

Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure…

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Added by John Robinson on January 9, 2017 at 6:00am — No Comments

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swethakumar posted a blog post

Where to study the NEBOSH Course in Bangalore?

NEBOSH is a UK-based board conveying professional qualifications based on Occupational Health and Safety Management which has the syllabus to evaluate the workplace health and safety issue with proper preventive measures.NEBOSH Training in Bangalore by Green World Group is accredited by the international HSE awarding bodies like IOSH, IEMA, and IIRSM.This qualification has been designed for all kinds of people such as individuals, Managers, Supervisors, and Employees who require more extensive…See More
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Shaun Alex posted a blog post

The 5 Best Outlets for Promotional Products in New York, New York

The most densely populated and the most populous city of the nation, New York is rightly labeled as the global power city of the USA. Not only does it serve as a dominant node for the global economic network, but in fact, it has been described as the cultural, financial and media capital of the world as well. The city also serves as the residing home of the United Nations’ headquarters. The impact which it imbues can be felt across various channels and mediums of supremacy for arts, commerce,…See More
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Harassment, Bullying, Gossip, Confrontational and Disruptive Behavior: A Manager’s Guide on How to Detox and Neutralize a Negative Workplace at Training Doyens 26468 E Walker Dr, Aurora, Colorado 80016

November 19, 2019 from 1pm to 2:30pm
OVERVIEWBad attitudes, jealousy and disruptive behavior will sabotage hospital morale, lower self-esteem and reduce teamwork and productivity. When toxic behavior infects a department, managers may be tempted to ignore it or give in, the wrong thing to do, but tolerating it is not a solution!This session will show you how to neutralize gossip and put a system in place to…See More
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EdbMails Office 365 Backup Software

Security approaches are principal to any organization’s protection and survival strategies. There are advanced types of attack that happen each day to take classified organization reports. To protect…Continue

Started by johnjorge 13 hours ago.

How to export EDB to PST successfully?

Microsoft Exchange Server maintains the data in EDB file format such as priv1.edb where it stores the private data of user mailbox, pub1.edb stores public data of user mailbox, .stm where these files…Continue

Started by marina paul on Friday.

Reasons for Office 365 email backup

The security enhancements and ease of access from anywhere are some of the major reasons why many organisations are willing to make the switch to the cloud from on-premises Exchange Servers.While…Continue

Started by johnjorge on Friday.

How EdbMails successful in deleted mailbox items recovery?

Are you wondering on how to get back your deleted mailbox items? Don’t be tensed to do the recovery of deleted mailbox items just go with EdbMails EDB to PST Converter tool that will show you how you…Continue

Started by clara dsouza on Thursday.

How EdbMails Exchange recovery reliable than manual methods?

When I immersed on manual method I couldn’t get actual result? Is there any other way to get successful result?Yes, Exchange server recovery third party tool works better, but how? Refer this…Continue

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